Low-Dose Dasatinib (50 mg Daily) Frontline Therapy in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: 5-Year Follow-Up Results

• Published in: Clinical lymphoma, myeloma and leukemia myeloma and leukemia, 2023-10, Vol.23 (10), p.742-748
• Main Authors: Gener-Ricos, Georgina, Haddad, Fadi G., Sasaki, Koji, Issa, Ghayas C., Skinner, Jeffrey, Masarova, Lucia, Borthakur, Gautam, Alvarado, Yesid, Garcia-Manero, Guillermo, Jabbour, Elias, Kantarjian, Hagop
• Format: Article
• Language: English
• Subjects: Complete cytogenetic response; Major molecular response; Outcome
• ISSN: 2152-2650; 2152-2669
• DOI: 10.1016/j.clml.2023.05.009

Dasatinib is a BCR::ABL1 tyrosine kinase inhibitor approved as frontline therapy at a 100 mg daily for chronic myeloid leukemia in chronic phase (CML-CP). The use of a lower dose of dasatinib (50 mg daily) has demonstrated better tolerance and improved outcomes compared with the standard dose. Here, we report the updated results in a large cohort with a 5-year follow-up. Patients with newly diagnosed CML-CP were eligible. Entry and response-outcome criteria were standard. Dasatinib was given as 50 mg orally daily. Eighty-three patients were included. At 3 months, 78 (96%) patients achieved BCR::ABL1 transcripts (IS) ≤10%, and at 12 months, 65 (81%) patients achieved BCR::ABL1 transcript (IS) ≤0.1%. The cumulative incidence of complete cytogenetic, major molecular, and deep molecular responses at 5 years were 98%, 95%, and 82%, respectively. Rates of failures due to resistance (n = 4; 5%) and toxicity (n = 4; 5%) were low. The 5-year overall survival was 96% and event-free survival 90%. No transformations to accelerated or blastic phase were observed. Grade 3 to 4 pleural effusions developed in 2% of patients. Dasatinib 50 mg daily is an effective and safe treatment for newly diagnosed CML-CP. Dasatinib 50 mg daily was given to 83 patients with newly diagnosed Ph- positive CML in chronic phase. The cumulative incidence of major molecular and deep molecular responses at 5 years were 95% and 82%, respectively. Only 5% had CML resistance at 5 years. The 5-year overall survival was 96%. Grade 3 to 4 pleural effusions were noted in 2%.